K211990

Substantially Equivalent

Rist 071 Radial Access Guide Catheter

Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product code: DQY
Advisory panel: Cardiovascular
Date received: 2021-06-28
Decision date: 2021-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.